Hagan 2008.
| Study characteristics | ||
| Methods | Trial design: open, randomised, crossover trial. Country principal investigators: Australia. Where trial conducted: Australia. Date of trial: between April and October 2006. Multi‐centre: no. Funder: SKINS Compression Garments, Sydney, NSW. Blinding: no. Lost to follow‐up: 3. | |
| Participants | Inclusion criteria: low to medium risk of DVT. Participants were aged 18 or older with confirmed booking on a flight (5 hours' minimum) with 48 hours between forward and return flight. Exclusion criteria: received medical advice to wear GCT in flight, previous history of DVT, on medication for cardiovascular disease, coagulation disorders, varicose veins, bone or joint problems, diabetes or hypertension, BMI ≥ 35, or neoplastic disease within previous 2 years. No. randomised: 50 No. analysed: 47. Age (years): 24 to 71 years. Sex: 35 M, 12 F. | |
| Interventions | Stocking was worn on both legs (tights) on either the outward flight or on the return. Type of stocking: SKINS travel and recovery garment, listed as class I medical device (SKINS Compression Garments Pty Ltd, Sydney, NSW; ID: 880116). 5 mmHg at ankle, 17 to 20 mmHg at calf, 10 mmHg above knee and 4 mmHg at buttocks. Length of flight: 9.6 hours (GCT), 9.7 hours (no GCT). Type of seat: not reported. Route and time of flight: not reported. Additional interventions: suggestions for in flight exercises given to both groups. | |
| Outcomes | Primary outcomes assessed: difference in change of ankle circumference (before flight and after landing) between control (no GCT) and treatment (GCT). Secondary outcomes assessed: leg pain, leg discomfort, perceived leg swelling, energy levels, alertness and ability to concentrate. |
|
| Funding | Skins Compression Garments of Sydney, NSW. | |
| Declarations of interest | "Melissa Hagan was contracted to conduct the study independently, and received no other funding from the company other than to conduct this research. Stephen Lambert is under contract as a scientific consultant for Skins Compression Garments. The study was initially designed by Stephen Lambert. Melissa Hagan independently collected, analysed and interpreted the data, and wrote the article. The agreement to publish the results was made prior to data collection with the Bellberry Human Research Ethics Committee, which approved this study. Skins Compression Garments had no influence over the decision to publish, and Melissa Hagan had final approval over the article’s content". | |
| Notes | Funding by manufacturers, study designed by manufacturers, study authors independently collected, analysed and reported data. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Used "...a computer generated randomisation sequence" |
| Allocation concealment (selection bias) | Low risk | "Random allocation achieved by giving participants a sealed envelope with instructions..." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcomes self‐reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All reported and intention‐to‐treat analysis used |
| Selective reporting (reporting bias) | Low risk | All reported |
| Other bias | Low risk | No evidence of other bias |